Allergic RhinitisPhase 3DESPREDNCT05214911
Fixed Dose Combination of Desloratadine / Prednisolone in the Treatment of Moderate Severe Allergic Rhinitis in Children
A Phase 3 study testing Desloratadine , Prednisolone and Desloratadine in people with Allergic Rhinitis, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial summary
Multicenter, randomized, parallel-group, double-blind, double-dummy, comparative clinical trial of the superiority of the fixed-dose combination of desloratadine 0.5 mg/mL and prednisolone 4 mg/mL from Eurofarma Laboratórios SA versus desloratadine 0.5 mg/mL in the treatment of moderate to severe persistent allergic… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Desloratadine , Prednisolone and Desloratadine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Jul 2024to 23 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≥ 6 years and ≤ 12 years.
- Diagnosis of moderate to severe persistent allergic rhinitis (PAR) according to ARIA (Allergic Rhinitis and Its Impact on Asthma) criteria.
- Sensitization to aeroallergens confirmed by the presence of a positive result on the immediate skin test (PRICK test) and/or by the presence of specific IgE.
- Total nasal symptom score (TNSS ) ≥ 8 points.
- Symptom intensity score "nasal obstruction" ≥ 2 points.
- Signing of the Informed Consent Form (ICF) by the legal guardian and the Informed Assent Form (IAF) before performing any study procedure.
Who cannot join
- Being using or having an indication for antibiotic therapy upon selection for the study.
- Use of prednisolone or other oral corticosteroids in the last seven (07) days.
- Presence of uncontrolled asthma.
- Covid-19 diagnosis within four (04) weeks prior to randomization.
- Positive for SARS-COV-2 rapid antigen test at the time of randomization.
- Known allergy to desloratadine, prednisolone or any component of the product formulations under investigation.
Show all 12Show fewer
- Presence of systemic fungal infections or uncontrolled infections.
- Presence of any serious or uncontrolled diseases, at the investigator's discretion.
- Presence of pregnancy or lactation.
- At the discretion of the investigator, female participants who are already of childbearing age must confirm the use of contraception or expressly declare that they are not at risk of pregnancy because they do not engage in sexual practices or do so in a non-reproductive manner.
- Participation in a clinical research protocol in the last 6 months, unless, according to the investigator's criteria, their participation in the study could imply a direct benefit for the participant.
- Presence of any condition that, at the investigator's discretion, renders the patient unfit to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter,Randomized, Parallel,Double-blind, Comparative Study of the Superiority of the Desloratadine 0.5mg/mL and Prednisolone 4 mg/mL Versus Desloratadine 0.5mg/mL in the Treatment of Persistent Allergic Rhinitis in Children (DESPRED)
Multicenter, randomized, parallel-group, double-blind, double-dummy, comparative clinical trial of the superiority of the fixed-dose combination of desloratadine 0.5 mg/mL and prednisolone 4 mg/mL from Eurofarma Laboratórios SA versus desloratadine 0.5 mg/mL in the treatment of moderate to severe persistent allergic rhinitis in children aged 6 to 12 years.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
Read the detailed description
Desloratadine and prednisolone are active pharmaceutical ingredients (APIs) already registered in the country as monodrugs. These products are widely used and their efficacy and safety are well known in daily clinical practice in the approved indications.
Once confirmed the absence of pharmacokinetic interaction between desloratadine and prednisolone in relative bioavailability studies, this phase 3 study will be conducted with the objective of demonstrating the superiority of the new FDC containing desloratadine and prednisolone over the isolated administration of desloratadine in treatment from moderate to severe allergic rhinitis in children. The aim is to provide a new effective, safe and well-tolerated therapeutic option for dealing with these cases.
Multicenter, randomized, parallel group, double blind, double-dummy, superiority comparative clinical trial.
Children aged ≥ 6 years and < 12 years with moderate to severe persistent allergic rhinitis unresponsive to optimal treatment, including daily use of intranasal corticosteroids, will be randomized in a 1:1 ratio to receive FDC desloratadine 0.5mg/mL/prednisolone 4mg/mL - gel for oral administration by Eurofarma Laboratórios SA (experimental drug) or desloratadine 0.5mg/mL - syrup, for five (05) days.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
- Conditions
- Allergic Rhinitis
- Being tested
- Desloratadine , Prednisolone, Desloratadine
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desloratadine , PrednisoloneDrug
FDC desloratadine 0.5 mg/mL/prednisolone 4 mg/mL from Eurofarma Laboratórios SA
DesloratadineDrug
Desloratadine 0.5 mg/mL (Desalex® - Eurofarma Laboratórios SA)
| Study group | Role | What they receive |
|---|---|---|
| Experimental drug (Desloratadine 0.5 mg/mL/Prednisolone 4 mg/mL) | Experimental | ADF Group 1 - Eurofarma drug association of Desloratadine 0.5 mg/mL / Prednisolone 4 mg/mL Receives: Drug: Desloratadine , Prednisolone |
| Active Comparator: Desalex® (Desloratadine 0.5 mg/mL) | Active comparator | Desalex® Group 2 - Eurofarma drug Desloratadine 0.5 mg/mL Receives: Drug: Desloratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total nasal symptom score (TNSS)
Primary objective: Demonstrate the superiority of the experimental drug (FDC desloratadine 0.5 mg/mL/prednisolone 4 mg/mL from Eurofarma Laboratórios SA) compared to desloratadine 0.5 mg/mL in alleviating symptoms of moderate/severe allergic rhinitis in children through the absolute variation of the total nasal symptom score (TNSS) five (05) days after the treatment start. The TNSS is determined by the sum of the intensity scores attributed to the symptoms of nasal obstruction, runny nose, nasal itching and sneezing in the last 24 hours. Each symptom is assessed using a 4-point categorical scale (0=absent symptom, 1=mild symptom, 2=moderate symptom, 3=intense symptom).
Measured: five (05) days after the treatment start
Secondary outcomes (1)
The total nasal symptom score (TNSS) ( efficacy)
Secondary objectives: To compare the efficacy of the experimental drug (FDC desloratadine 0.5 mg/mL/prednisolone 4 mg/mL from Eurofarma Laboratórios SA) against desloratadine 0.5 mg/mL in alleviating symptoms of moderate/severe allergic rhinitis in children through TNSS. The TNSS is determined by the sum of the intensity scores attributed to the symptoms of nasal obstruction, runny nose, nasal itching and sneezing in the last 24 hours. Each symptom is assessed using a 4-point categorical scale (0=absent symptom, 1=mild symptom, 2=moderate symptom, 3=intense symptom).
Measured: three (03) days after the treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start8 Jul 2024
- Primary completion23 Mar 2025
- Study completion23 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214911
- Sponsor's protocol ID
- EF177
- Acronym
- DESPRED
- Status last verified
- Oct 2026
- First submitted
- 13 Dec 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter,Randomized, Parallel,Double-blind, Comparative Study of the Superiority of the Desloratadine 0.5mg/mL and Prednisolone 4 mg/mL Versus Desloratadine 0.5mg/mL in the Treatment of Persistent Allergic Rhinitis in Children (DESPRED)
- ClinicalTrials.gov ID
- NCT05214911
- Acronym / sponsor ID
- DESPRED / EF177
- Conditions
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 23 Mar 2025 (actual)
- Study completion
- 23 Mar 2025 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter, randomized, parallel-group, double-blind, double-dummy, comparative clinical trial of the superiority of the fixed-dose combination of desloratadine 0.5 mg/mL and prednisolone 4 mg/mL from Eurofarma Laboratórios SA versus desloratadine 0.5 mg/mL in the treatment of moderate to severe persistent allergic rhinitis in children aged 6 to 12 years.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
Detailed description
Desloratadine and prednisolone are active pharmaceutical ingredients (APIs) already registered in the country as monodrugs. These products are widely used and their efficacy and safety are well known in daily clinical practice in the approved indications.
Once confirmed the absence of pharmacokinetic interaction between desloratadine and prednisolone in relative bioavailability studies, this phase 3 study will be conducted with the objective of demonstrating the superiority of the new FDC containing desloratadine and prednisolone over the isolated administration of desloratadine in treatment from moderate to severe allergic rhinitis in children. The aim is to provide a new effective, safe and well-tolerated therapeutic option for dealing with these cases.
Multicenter, randomized, parallel group, double blind, double-dummy, superiority comparative clinical trial.
Children aged ≥ 6 years and < 12 years with moderate to severe persistent allergic rhinitis unresponsive to optimal treatment, including daily use of intranasal corticosteroids, will be randomized in a 1:1 ratio to receive FDC desloratadine 0.5mg/mL/prednisolone 4mg/mL - gel for oral administration by Eurofarma Laboratórios SA (experimental drug) or desloratadine 0.5mg/mL - syrup, for five (05) days.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental drug (Desloratadine 0.5 mg/mL/Prednisolone 4 mg/mL) | Experimental | Drug: Desloratadine , PrednisoloneADF Group 1 - Eurofarma drug association of Desloratadine 0.5 mg/mL / Prednisolone 4 mg/mL |
| Active Comparator: Desalex® (Desloratadine 0.5 mg/mL) | Active comparator | Drug: DesloratadineDesalex® Group 2 - Eurofarma drug Desloratadine 0.5 mg/mL |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age ≥ 6 years and ≤ 12 years.
- Diagnosis of moderate to severe persistent allergic rhinitis (PAR) according to ARIA (Allergic Rhinitis and Its Impact on Asthma) criteria.
- Sensitization to aeroallergens confirmed by the presence of a positive result on the immediate skin test (PRICK test) and/or by the presence of specific IgE.
- Total nasal symptom score (TNSS ) ≥ 8 points.
- Symptom intensity score "nasal obstruction" ≥ 2 points.
Key exclusion criteria (12 listed)
- Being using or having an indication for antibiotic therapy upon selection for the study.
- Use of prednisolone or other oral corticosteroids in the last seven (07) days.
- Presence of uncontrolled asthma.
- Covid-19 diagnosis within four (04) weeks prior to randomization.
- Positive for SARS-COV-2 rapid antigen test at the time of randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desloratadine , PrednisoloneFDC desloratadine 0.5 mg/mL/prednisolone 4 mg/mL from Eurofarma Laboratórios SA | Drug | Experimental drug (Desloratadine 0.5 mg/mL/Prednisolone 4 mg/mL) |
| DesloratadineDesloratadine 0.5 mg/mL (Desalex® - Eurofarma Laboratórios SA) | Drug | Active Comparator: Desalex® (Desloratadine 0.5 mg/mL) |
Primary outcome
The total nasal symptom score (TNSS)
Time frame: five (05) days after the treatment start
Primary objective: Demonstrate the superiority of the experimental drug (FDC desloratadine 0.5 mg/mL/prednisolone 4 mg/mL from Eurofarma Laboratórios SA) compared to desloratadine 0.5 mg/mL in alleviating symptoms of moderate/severe allergic rhinitis in children through the absolute variation of the total nasal symptom score (TNSS) five (05) days after the treatment start. The TNSS is determined by the sum of the intensity scores attributed to the symptoms of nasal obstruction, runny nose, nasal itching and sneezing in the last 24 hours. Each symptom is assessed using a 4-point categorical scale (0=absent symptom, 1=mild symptom, 2=moderate symptom, 3=intense symptom).
1 secondary outcome
The total nasal symptom score (TNSS) ( efficacy)
Time frame: three (03) days after the treatment start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desloratadine , Prednisolone and Desloratadine in people with Allergic Rhinitis, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total nasal symptom score (TNSS) (time frame: five (05) days after the treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.